NCT06881784phase 3recruiting

Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)

Revolution Medicines, Inc.

ClinicalTrials.gov

590

Enrollment · estimated

Countries · 153 sites

2027-12

Primary completion

13 days ago

Record updated

Commercial relevance

Trial record references molecular eligibility required, central lab testing referenced.

Molecular eligibility requiredCentral lab testing

Biomarker requirement language

Pathologically confirmed NSCLC, either locally advanced or metastatic, not amenable to curative surgery or radiotherapy.
Documented RAS mutation status, defined as Nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61).

Change timeline

No changes detected yet. The first refresh records a baseline snapshot; subsequent refreshes generate field-level changes.

Signals from this trial

New trial
66/100
Opportunity
New phase 3 trial NCT06881784 posted by Revolution Medicines, Inc.: "Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)".
ClinicalTrials.gov record updated 12 days ago.

Eligibility — raw, for validation

Inclusion Criteria:

* At least 18 years old and has provided informed consent.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Pathologically confirmed NSCLC, either locally advanced or metastatic, not amenable to curative surgery or radiotherapy.
* Measurable disease per RECIST v1.1.
* Adequate organ function (bone marrow, liver, kidney, coagulation).
* One to two prior lines of therapy including an anti-PD-1/anti-PD(L)-1 agent and platinum-based chemotherapy.
* Documented RAS mutation status, defined as Nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61).
* Able to take oral medications.

Exclusion Criteria:

* Prior therapy with direct RAS-targeted therapy or docetaxel.
* Untreated central nervous system (CNS) metastases.
* Medically significant comorbidities (significant cardiovascular disease, lung disease, or impaired GI function).
* Ongoing anticancer therapy.
* Pregnant or breastfeeding.